Cereform breast implants product recall

Just when we thought it couldn’t get much worse after the PIP recall, here we go again!

Earlier this month, the French government recalled all unused Cereform breast implants made by Cereplas because the company was failing sterilization standards in the manufacturing process.

Australian distributor of the product, Medical Vision Australia Plastic & Cosmetic, has advised Australian surgeons not to use them while Australia’s Therapeutic Goods Administration investigates whether they are safe to use. They caution that women who have not faced infection soon after surgery likely won’t get one, but regulators have stopped their further use in Australia in favor of an investigation first.

The ANSM in the EU has suspended the marketing, distribution and use of breast implants and sizers from Cereplas until the company achieves compliance with regulations, which include control of the process of sterilization and qualification of equipment used in production. Cereplas’ CE marking Certificates for its breast implants have also been suspended.

Updated information – product recall – 11 March 2014

Let’s hope this latest mess is sorted out sooner than later!

With love and blessings,
Lynne x

Updated information – product recall

11 March 2014

Following on from a safety advisory on 21 February regarding Cereform gel-filled breast implants, the Australian distributor, Medical Vision Australia Plastic & Cosmetic, has undertaken a recall of the implants and associated sizers.

A similar recall was undertaken in France after the French regulatory authority, Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), found that the validation of the sterilisation provider was not consistent with the requirements of international regulatory standards. As identified in the TGA’s previous safety advisory for Cereform gel-filled breast implants, information from the ANSM states that the French recall is being undertaken because of regulatory non-compliance. They have further stated that they have not identified a health risk associated with this issue.

The TGA is not aware of any increased infection rates among Australian patients receiving Cereform breast implants.

As detailed in the TGA safety advisory for Cereform gel-filled breast implants, Medical Vision Australia Plastic & Cosmetic had already taken steps before the recall was undertaken to ensure Cereform breast implants were not implanted until the issue was resolved.

Medical Vision Australia Plastic & Cosmetic has undertaken these actions in consultation with the TGA.

Information for consumers

If you have received a Cereform breast implant and did not experience an infection soon after the surgery, then you should not experience any problems associated with this issue. An infection would be recognised by localised pain at the site of the implant and possibly an increase in body temperature.

If you have any questions or concerns about this issue, contact your general practitioner or surgeon for individual clinical assessment and advice.

Information for health professionals

If you have a patient who has received a Cereform breast implant, be alert to the issue and the potential complications for patients. Reassure them that if they were going to experience an infection related to this issue, it would occur in the immediate post-operative period.

Medical Vision Australia Plastic & Cosmetic has written to all health professionals and facilities using Cereform breast implants and sizers. If you are responsible for these devices, but have not yet been contacted by Medical Vision Australia Plastic & Cosmetic, call 1300 661 559.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA’s monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual’s medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.

Content last updated: Tuesday, 11 March 2014

Web page last updated: Tuesday, 11 March 2014

URL: http://www.tga.gov.au/safety/alerts-device-cereform-breast-implants-140311.htm

 

 

 

 

cereform

Just when we thought it couldn’t get much worse after the PIP recall, here we go again!

Earlier this month, the French government recalled all unused Cereform breast implants made by Cereplas because the company was failing sterilization standards in the manufacturing process.

Australian distributor of the product, Medical Vision Australia Plastic & Cosmetic, has advised Australian surgeons not to use them while Australia’s Therapeutic Goods Administration investigates whether they are safe to use. They caution that women who have not faced infection soon after surgery likely won’t get one, but regulators have stopped their further use in Australia in favor of an investigation first.

The ANSM in the EU has suspended the marketing, distribution and use of breast implants and sizers from Cereplas until the company achieves compliance with regulations, which include control of the process of sterilization and qualification of equipment used in production. Cereplas’ CE marking Certificates for its breast implants have also been suspended.

Updated information – product recall – 11 March 2014

Let’s hope this latest mess is sorted out sooner than later!

With love and blessings,
Lynne x

Updated information – product recall

11 March 2014

Following on from a safety advisory on 21 February regarding Cereform gel-filled breast implants, the Australian distributor, Medical Vision Australia Plastic & Cosmetic, has undertaken a recall of the implants and associated sizers.

A similar recall was undertaken in France after the French regulatory authority, Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), found that the validation of the sterilisation provider was not consistent with the requirements of international regulatory standards. As identified in the TGA’s previous safety advisory for Cereform gel-filled breast implants, information from the ANSM states that the French recall is being undertaken because of regulatory non-compliance. They have further stated that they have not identified a health risk associated with this issue.

The TGA is not aware of any increased infection rates among Australian patients receiving Cereform breast implants.

As detailed in the TGA safety advisory for Cereform gel-filled breast implants, Medical Vision Australia Plastic & Cosmetic had already taken steps before the recall was undertaken to ensure Cereform breast implants were not implanted until the issue was resolved.

Medical Vision Australia Plastic & Cosmetic has undertaken these actions in consultation with the TGA.

Information for consumers

If you have received a Cereform breast implant and did not experience an infection soon after the surgery, then you should not experience any problems associated with this issue. An infection would be recognised by localised pain at the site of the implant and possibly an increase in body temperature.

If you have any questions or concerns about this issue, contact your general practitioner or surgeon for individual clinical assessment and advice.

Information for health professionals

If you have a patient who has received a Cereform breast implant, be alert to the issue and the potential complications for patients. Reassure them that if they were going to experience an infection related to this issue, it would occur in the immediate post-operative period.

Medical Vision Australia Plastic & Cosmetic has written to all health professionals and facilities using Cereform breast implants and sizers. If you are responsible for these devices, but have not yet been contacted by Medical Vision Australia Plastic & Cosmetic, call 1300 661 559.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA’s monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual’s medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.

Content last updated: Tuesday, 11 March 2014

Web page last updated: Tuesday, 11 March 2014

URL: http://www.tga.gov.au/safety/alerts-device-cereform-breast-implants-140311.htm

 

 

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